Quality of Drugs and Drug Products

Overall aim of the module

After the overall aim of the module, which is taught as part of the Pharmaceutical Chemistry 2

course, is the engage the student with the notion of composition of pharmaceutical products and

their chemical nature. This is then related to the ascertaining the composition of the

pharmaceutical products, the methods how to do this. The principles of these methods are

discussed and analysed in detail.

Prior knowledge needed by the students for the module

Chemistry 101 and 102, Pharmaceutical Biochemistry 1 and Foundations of Pharmacy

Textbook for the analysis part of the Module subject matter

 https://www.sohailuniversity.edu.pk/wp-content/uploads/2018/12/Pharmaceutical-Drug-Analysis-ASHUTOSH-

KAR.pdf

Topics in the Quality of Drugs module – Identification and volumetric analysis

1) Basics of identification of the pharmaceutical products

- Definition of basic terms in pharmaceutical analysis

- Batch, precision, accuracy and other terms – calculation of some of them

- Role of measurements of appearance, appearance in solution, meting point, boiling point,

refractive index, solubility and related properties of pharmaceutical products in the simple

approaches to identification of pharmaceutical products

This topic was covered in the Lecture 1 - identification and volumetric analysis with

narration and sections in Japanese pharmacopeia (which is available at:

https://www.mhlw.go.jp/file/06-Seisakujouhou-11120000-

Iyakushokuhinkyoku/JP17_REV_1.pdf for download as a pdf file, e.g. 2.45 Refractive

Index Determination on page 55 and 2.57 Boiling Point and Distilling Range

Test on page 78).

2) Acido-basic equilibria and pH calculations/acido-basic titration in pharmaceutical analysis

- This is revision of the Brønsted-Lowry theory of acids and bases, the calculation of the pH of

various types of solutions such as strong/weak acids, strong/weak bases and buffers

Here the class is requested to look at slides 23-51 from the original slides Identification and

titrations file. These slides, without commentary as none should be needed as the slides

constitute only revision of previously covered curriculum and as reading the slides is self0-

explanatory, have been placed on the RUconnected website as Acido-basic equilibria and

pH calculations. The class needs to complete this topic through self-study by reading

chapter IIA section 4. – Aqueous titrations (pages 95-105) in the textbook entitled the

Pharmaceutical Drug Analysis - text for volumetric analysis. This textbook link is available

on RUconnected and also at https://www.sohailuniversity.edu.pk/wp-

content/uploads/2018/12/Pharmaceutical-Drug-Analysis-ASHUTOSH-KAR.pdf (website

accessed March 27, 2021).

3) Absorption spectroscopy

- Types of electromagnetic radiation and introduction to their use in the analysis of

pharmaceutical products
 - Quantification of absorption of electromagnetic radiation – definition of a spectrum and the

Lambert-Beer law

- Principles of energy absorption, i.e. the electron excitation and their transition between

various types of molecular orbitals

- Definition of a chromophore and the principles of UV/VIS spectroscopy

- Basics of Instrumentation and the description of the composition of a

spectrometer/spectrophotometer

- Additional topics as outlined in the relevant lecture slides

This topic was covered in the lectures entitled Absorption spectroscopy with commentary

and Absorption spectroscopy with commentary 2. The class is requested to disregard any

reference to practicals in the slides from Absorption spectroscopy.

4) Complexometric titrations

- Definition of the coordination covalent bond and the difference/common features with the

covalent bond

- Definition of a complex as chemical compound – ligand vs. metal

- Difference between unidentate and multi-dentate ligands

- Standardisation of complexometric ligands and the definition of the stability constant

- Direct, indirect and back complexometric analyses in pharmaceutical analysis

This topic was covered in the lectures entitled Complexometric titrations with commentary.

The class needs to complete this topic through self-study by reading chapter IID section 9. –

Complexometric titrations (pages 161-172) in the textbook entitled the Pharmaceutical

Drug Analysis - text for volumetric analysis. This textbook link is available on
RUconnected and also at https://www.sohailuniversity.edu.pk/wp-

content/uploads/2018/12/Pharmaceutical-Drug-Analysis-ASHUTOSH-KAR.pdf (website

accessed March 27, 2021).

5) Non-aqueous titrations – in this section the class will see the difference between the use of

water as a solvent and various non-aqueous solvents. The solvents which are non-aqueous can be

divided into prophilic, protogenic and amphiprotic. The titrant volume compensation for the

temperature influence, examples of the titrants in non-aqueous acidimetry and alkalimetry.

In the text book, this topic is covered in chapter 5 on page 106-124. Slides are available on

the RUconnected.

6) Redox titration intro – permanganate titrations please read section 6.1-6.3.4.1 in the text book.

7) Examples of the non-aqueous titrations and redox titrations for oils and fats – in this section

the class will engage with practical examples of the analysis of oils and fats as non-aqueous

environments or solvents, e.g. the determination of iodine value, acid value, saponification value,

peroxide value. The class will get an understanding of the role of non-aqueous alkalimetry

titrants in the acido-basic titrations which are relevant to pharmaceutical analysis. The role of

back titration (indirect titration accourding to Kar – Pharamceutical Analysis) will be

demonstrated on the example of the use of iodometric titration with the sodium thiosulphate as

the titrant in oil/fat analysis.

In the text book, this topic is covered in chapter IIB section 7 on pages 137-150. Slides are

available on the RUconnected.

8) Basics of pharmaceutical packaging – chemical nature of the most common packaging

materials used in the pharmaceutical industry, difference between primary and secondary

packagings, potential influence of the packaging materials on the properties of the

pharmaceutical product store in them, chemical properties of the most common packaging

materials and their assessment according to pharmacopeial materials.